Studies suggest that the addition of antiangiogenic agents to conventional therapeutic strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has become an important treatment option and its combination with chemotherapy is now being one of the standard first line therapy. This phase II study was conducted to determine the efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in advanced colorectal cancer.

Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.

At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques

ECOG performance status 0-1

Life expectancy > 3 months

ECG is normal

Exclusion Criteria:

Pregnant or lactating woman

Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy,and any prior 5－fluorouracil treatment, with the exception of adjuvant therapy given > 6 months prior to the beginning of study therapy

Any prior endostatin treatment

known hypersensitivity to 5-fluorouracil,oxaliplatin,leucovorin

History of persistent neurosensory disorder including but not limited to peripheral neuropathy

known DPD deficiency

Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01529164